Non-small Cell Lung Cancer
Conditions
Brief summary
This study involves the evaluation of a decision support tool, based on the patient version of the NCCN guidelines, for the non-small cell lung cancer patient population.
Detailed description
This study involves the evaluation of a decision support tool, based on the patient version of the NCCN guidelines, for the non-small cell lung cancer patient population. The decision support tool is offered by a trained coordinator to the patient and then utilized during an initial consultation. Patients complete forms before and after the visit indicating their level of decisional conflict, satisfaction, and satisfaction with decision. Pre-determined indices of quality of care were also collected by the study team.
Interventions
BEHAVIORALDecision support tool
Internet-Based, interactive decision support tool
Sponsors
National Comprehensive Cancer Network
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over age of 18 * Able to provide informed consent * Able to use a web-based interface * Histologically proven or clinically apparent diagnosis of non-small cell lung cancer * Newly diagnosed, with new primary occurrence of NSCLC, or diagnosed with a new recurrence or new progression of existing disease, and not yet treated for the new problem * Being seen in consultation at thoracic oncology clinics
Exclusion criteria
* Unable to fill out questionnaires * Already treated for the current diagnosis of a new primary occurrence of NSCLC, or already treated for the new recurrence or new progression of existing disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations | 1 Day | Participants explored individually tailored decision trees derived from the NCCN guidelines. Six benchmarks of quality care derived from the guidelines were evaluated: (1) documented smoking cessation counseling in active smokers, (2) adjuvant chemotherapy for patients with stage IB to IIB NSCLC after surgery, (3) pathologic mediastinal staging in patients with stage III NSCLC before surgery, (4) pathologic mediastinal staging in patients with stage III NSCLC before nonsurgical management, (5) definitive chemoradiotherapy for patients with stage III NSCLC not undergoing surgery, and (6) molecular testing for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) alterations for patients with stage IV NSCLC. Because the decision trees were tailored, not all participants evaluated all 6 benchmarks. The percentage of participants who interacted with each benchmark and demonstrated quality of care will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire | 1 Day | The Patient Satisfaction with Health Care Decision (SWD) Questionnaire is a six-item survey with item responses ranging from 1 -5 with a higher value indicating a higher degree of satisfaction or agreement with the statement. The median score of each item and the interquartile range will be reported. |
| Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) | 1 Day | Participants preferred style of decision making with their physician will be assessed using the Decision Making Preference Questionnaire (DMPQ). The DMPQ consists of a single question with five choices, ranging from a preference to have the doctor make all of the decisions (passive) to the patient making all of the decisions themselves about their treatment (active) or a combination of shared decision making ranging from the most passive in self-decision making preference to the most active in self-decision making. The number of participants by response will be reported. |
| Median Change in Decisional Conflict Scale (DCS) Score Over Time | 1 Day | Change in level of decisional conflict will be assessed by the DCS completed before and after consultation. The DCS is a scale designed to measure participants' uncertainty in making health-related decisions, factors contributing to uncertainty, and participants perceived effective decision-support. The DCS has a total of 16 items and uses a five-point Likert scale for each item. The total score ranging from 0-64 is divided by 16 and then multiplied by 25 to calculate a final total score with 0 indicating low conflict and 100 indicating high conflict. The median change in score over time and the interquartile range will be reported. |
| Median Scores on the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17) | 1 Day | The NCCN/FACT Lung Cancer Symptom Index-17 (NFLSI-17) is a brief symptom index for patients with advanced lung cancer. The NFLSI-17 is a 17-item patient-reported questionnaire. Each item is rated on a 5-point Likert scale ranging from 0 = Not at all to 4 = Very much with a total score range of 0-68. The questionnaire includes three subscales: Disease-Related Subscale, Treatment Side Effects, and Functional Well-Being with higher scores indicating lower overall symptoms. |
| Percentage of Participants With Reported Agreement at Post Consultation With Physician | 1 Day | The percentage of participants who completed the post-consultation questionnaire and reported achieving agreement on treatment recommendations between the participants and the physician with respect to treatments discussed and recommended, prognosis, and expected tolerance will be reported. |
| Median Total Score on the Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire | 1 Day | The Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale is a 36-item self-report instrument that measures multidimensional quality of life for patients with lung cancer. Each item is rated on a 5-point Likert scale ranging from 0 = Not at all to 4 = Very much with a total score range of 0-144, and higher scores indicating a better quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decision Support Tool Participants receive training in use of a decision support tool by a trained coordinator at a single clinic visit | 76 |
| Total | 76 |
Baseline characteristics
| Characteristic | Decision Support Tool |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 42 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 51 Participants |
| Region of Enrollment United States | 76 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 76 |
| other Total, other adverse events | 0 / 76 |
| serious Total, serious adverse events | 0 / 76 |
Outcome results
Primary
Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations
Participants explored individually tailored decision trees derived from the NCCN guidelines. Six benchmarks of quality care derived from the guidelines were evaluated: (1) documented smoking cessation counseling in active smokers, (2) adjuvant chemotherapy for patients with stage IB to IIB NSCLC after surgery, (3) pathologic mediastinal staging in patients with stage III NSCLC before surgery, (4) pathologic mediastinal staging in patients with stage III NSCLC before nonsurgical management, (5) definitive chemoradiotherapy for patients with stage III NSCLC not undergoing surgery, and (6) molecular testing for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) alterations for patients with stage IV NSCLC. Because the decision trees were tailored, not all participants evaluated all 6 benchmarks. The percentage of participants who interacted with each benchmark and demonstrated quality of care will be reported.
Time frame: 1 Day
Population: Nine participants were missing survey results preventing calculation for this measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Decision Support Tool | Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations | Documented smoking cessation counseling or intervention in active smokers | 80 percentage of participants |
| Decision Support Tool | Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations | Adjuvant chemotherapy for participants with stage IB-IIB disease following surgery | 0 percentage of participants |
| Decision Support Tool | Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations | Pathologic mediastinal staging completed before surgery for patients with stage III disease | 50 percentage of participants |
| Decision Support Tool | Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations | Pathologic mediastinal staging before treatment initiation for stage III not undergoing surgery | 28.6 percentage of participants |
| Decision Support Tool | Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations | Initial chemoradiotherapy for participants with stage III disease not undergoing surgery | 64.3 percentage of participants |
| Decision Support Tool | Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations | Testing for EGFR or ALK gene alteration status for participants with stage IV disease | 91.3 percentage of participants |
Secondary
Median Change in Decisional Conflict Scale (DCS) Score Over Time
Change in level of decisional conflict will be assessed by the DCS completed before and after consultation. The DCS is a scale designed to measure participants' uncertainty in making health-related decisions, factors contributing to uncertainty, and participants perceived effective decision-support. The DCS has a total of 16 items and uses a five-point Likert scale for each item. The total score ranging from 0-64 is divided by 16 and then multiplied by 25 to calculate a final total score with 0 indicating low conflict and 100 indicating high conflict. The median change in score over time and the interquartile range will be reported.
Time frame: 1 Day
Population: Nine participants did not complete the questionnaire
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Decision Support Tool | Median Change in Decisional Conflict Scale (DCS) Score Over Time | 20 score on a scale |
Secondary
Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire
The Patient Satisfaction with Health Care Decision (SWD) Questionnaire is a six-item survey with item responses ranging from 1 -5 with a higher value indicating a higher degree of satisfaction or agreement with the statement. The median score of each item and the interquartile range will be reported.
Time frame: 1 Day
Population: Six participants did not complete the questionnaire
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Decision Support Tool | Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire | I am satisfied that I am adequately informed about the issues important to my decision | 4 score on a scale |
| Decision Support Tool | Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire | The decision I made was the best decision possible for me personally | 4 score on a scale |
| Decision Support Tool | Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire | I am satisfied that my decision was consistent with my personal values | 4 score on a scale |
| Decision Support Tool | Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire | I expect to successfully carry out (or continue to carry out) the decision I made | 4 score on a scale |
| Decision Support Tool | Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire | I am satisfied that this was my decision to make | 4 score on a scale |
| Decision Support Tool | Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire | I am satisfied with my decision | 4 score on a scale |
Secondary
Median Scores on the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17)
The NCCN/FACT Lung Cancer Symptom Index-17 (NFLSI-17) is a brief symptom index for patients with advanced lung cancer. The NFLSI-17 is a 17-item patient-reported questionnaire. Each item is rated on a 5-point Likert scale ranging from 0 = Not at all to 4 = Very much with a total score range of 0-68. The questionnaire includes three subscales: Disease-Related Subscale, Treatment Side Effects, and Functional Well-Being with higher scores indicating lower overall symptoms.
Time frame: 1 Day
Population: data not collected
Secondary
Median Total Score on the Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire
The Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale is a 36-item self-report instrument that measures multidimensional quality of life for patients with lung cancer. Each item is rated on a 5-point Likert scale ranging from 0 = Not at all to 4 = Very much with a total score range of 0-144, and higher scores indicating a better quality of life.
Time frame: 1 Day
Population: Two participants did not complete the questionnaire.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Support Tool | Median Total Score on the Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire | 67 score on a scale |
Secondary
Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ)
Participants preferred style of decision making with their physician will be assessed using the Decision Making Preference Questionnaire (DMPQ). The DMPQ consists of a single question with five choices, ranging from a preference to have the doctor make all of the decisions (passive) to the patient making all of the decisions themselves about their treatment (active) or a combination of shared decision making ranging from the most passive in self-decision making preference to the most active in self-decision making. The number of participants by response will be reported.
Time frame: 1 Day
Population: Five participants did not complete the questionnaire
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decision Support Tool | Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) | Doctor should make the decisions | 5 Participants |
| Decision Support Tool | Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) | Doctor should make the decisions but strongly consider my opinion | 12 Participants |
| Decision Support Tool | Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) | Doctor and I should make the decisions together | 39 Participants |
| Decision Support Tool | Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) | I should make decisions but strongly consider the doctor's opinion | 13 Participants |
| Decision Support Tool | Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) | I should make the decision | 2 Participants |
Secondary
Percentage of Participants With Reported Agreement at Post Consultation With Physician
The percentage of participants who completed the post-consultation questionnaire and reported achieving agreement on treatment recommendations between the participants and the physician with respect to treatments discussed and recommended, prognosis, and expected tolerance will be reported.
Time frame: 1 Day
Population: Only 45 participants completed the questionnaire
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decision Support Tool | Percentage of Participants With Reported Agreement at Post Consultation With Physician | 93.3 percentage of participants |